PAIN RELIEVING

Manufacturer
Medhome Pharma Inc
Effective date
2025-10-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:40:05

Label at a glance#

ProductPAIN RELIEVING
Active ingredientLIDOCAINE
Label structure16 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% ...... Purpose: Topical Anesthetic

OTC - PURPOSE SECTION

Topical Anesthetic

USE IN SPECIFIC POPULATIONS SECTION

For temporary relief of pain

WARNINGS SECTION

For external use only

OTC - ASK DOCTOR/PHARMACIST SECTION

localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
Conditions worsen
Symptoms persists for more than 7 days
Symptoms clear up and occur again within a few days

OTC - WHEN USING SECTION

Use only as directed
Avoid contact with the eyes, mucous membranes or rashed
Do not bandage tightly

OTC - DO NOT USE SECTION

More than 1 patch at a time
On wounds or damaged skin
With a heating pad
If you are allergic to any ingredients of this product

OTC - STOP USE SECTION

localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
Conditions worsen
Symptoms persists for more than 7 days
Symptoms clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Adult and Children 12 years of age and over:

Clean and dry affected area
Remove film from patch and apply to the skin (see illustration)
Apply 1 patch at a time to affected area, not more than 3 to 4 times daily
Remove patch from the skin after at most 8-hour application

Children under 12 years of age: Consult a doctor

DOSAGE & ADMINISTRATION SECTION

This is a strip, patch dosage form.

The active ingredient strength is 4% w/w.

One patch one time, no more than 8 hours one time.

INACTIVE INGREDIENT SECTION

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water

OTC - QUESTIONS SECTION

E-mail:CS@pharmacychoiceUSA.com

OTHER SAFETY INFORMATION

Avoid storing product in direct sunlight
Protect product from excessive moisture

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1111

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN1
1737778lidocaine 0.04 MG/MG Medicated PatchSCD1
1737778lidocaine 4 % Medicated PatchSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X004VFT3IL15.jpg
Data codeCode 128X004VVK4PB30.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84007-160-01PAIN RELIEVING12 g in 1 PATCHPATCH121
84007-160-15PAIN RELIEVING15 in 1 BOXPATCH151
84007-160-30PAIN RELIEVING30 in 1 BOXPATCH301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84007-16084007-160-01, 84007-160-15, 84007-160-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEVINGLIDOCAINEMedhome Pharma Inc41cb1135-84e0-0c9a-e063-6294a90ada962025-10-22WarningsExact identifier
ndc (package): 84007-160-30
ndc (package): 84007-160-15
ndc (package): 84007-160-01
ndc (product): 84007-160
ndc11 (package): 84007016030
ndc11 (package): 84007016001
ndc11 (package): 84007016015
spl id: 41cb1135-84e1-0c9a-e063-6294a90ada96
spl set id: 41cb1135-84e0-0c9a-e063-6294a90ada96

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.